TAVI was performed as previously described. 24 (link) Vascular access was transfemoral using the Edwards SAPIEN/XT (Edwards Lifesciences, Irvine, CA) or the Medtronic CoreValve Revalving System (Medtronic Inc., Minneapolis, MN), transapical for the Edwards SAPIEN/XT or self-expanding Symetis ACURATE TA valve (Symetis Inc, Switzerland) or transsubclavian using the Medtronic CoreValve Revalving System.
Corevalve revalving system
Manufactured by Medtronic
Sourced in United States
The CoreValve Revalving System is a medical device designed for the treatment of aortic valve stenosis. It is a minimally invasive transcatheter aortic valve replacement (TAVR) system that allows for the implantation of a new aortic valve without open-heart surgery. The device is composed of a self-expanding nitinol frame with a pericardial tissue valve.
Automatically generated - may contain errors
Lab products found in correlation
Edwards sapien xt, by Edwards Lifesciences (1 mentions)
Edwards sapien xt valve, by Edwards Lifesciences (1 mentions)
Edwards sapien, by Edwards Lifesciences (1 mentions)
Edwards sapien valve, by Edwards Lifesciences (1 mentions)
Sapien and sapien xt, by Edwards Lifesciences (1 mentions)
Double pro glide, by Abbott (1 mentions)
7 protocols using corevalve revalving system
1
Transcatheter Aortic Valve Implantation
2
Transfemoral TAVR Valve Implantation
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TAVR procedures have already been described in detail. 9, 10 (link) The balloon-expandable Edwards SAPIEN-XT valve (Edwards Lifesciences) and the self-expandable Medtronic CoreValve Revalving System (Medtronic) are clinically approved in Japan. The prosthesis size (20, 23, 26, or 29 mm for Edwards SAPIEN-XT valve and 26, 29 mm for CoreValve Revalving System) was determined on the basis of preprocedural echocardiographic and multidetector computed tomographic findings. The devices were delivered by the femoral artery, iliac artery, apical routes, aortic routes, or subclavian approach. Criteria for selection of the transfemoral (TF), iliac, apical, direct aorta, and subclavian approach included the size, calcification, and tortuosity of the aortoiliofemoral arterial tree and the ratio between sheath size and minimum femoral size. Procedural and other complications during TAVR were evaluated according to the VARC-2 criteria (Valve Academic Research Consortium-2). 11 (link) Information on the possible occurrence or cause of death was obtained from the treating hospital or by calling the patient's family directly. The medical ethics committee at each hospital approved this study protocol, and written informed consent was obtained from all patients before undergoing TAVR.
3
Comparative TAVI and AVR Procedures
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Both TAVI and AVR were performed under general anesthesia. The TAVI was carried out through the transfemoral (primary choice), subclavian, or transaortic routes using the CoreValve Re Valving System (Medtronic, Inc, Minneapolis, MN) or Edwards Sapien (Edwards Lifesciences Inc, Irvine, CA) according to standard protocols [8] (for details see Appendix). All patients received dual antiplatelet therapy (aspirin and clopidogrel) for 3 months, then lifelong aspirin. The AVR was performed through a full or mini-sternotomy and received aspirin for 3 months.
4
Transcatheter Aortic Valve Implantation Procedure
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The TAVI procedure has previously been reported in detail.12 (link)
15 (link)
20 (link) In brief, the procedure consists in the following: the preferred access route was the femoral artery; other access sites (subclavian or carotid artery, transaortic, or transapical) were considered when femoral access was not suitable due to severe femoral artery disease; the femoral artery was punctured percutaneously and closed using a suture device, while the other access sites were managed surgically. Two commercially available systems were used: a self-expandable prosthesis, namely the Medtronic CoreValve Revalving System (Medtronic, Minneapolis, Minnesota, USA); a balloon-expandable prosthesis, the Edwards SAPIEN valve (Edwards Lifesciences, Irvine, California, USA). All patients provided written informed consent before the TAVI procedure.
15 (link)
20 (link) In brief, the procedure consists in the following: the preferred access route was the femoral artery; other access sites (subclavian or carotid artery, transaortic, or transapical) were considered when femoral access was not suitable due to severe femoral artery disease; the femoral artery was punctured percutaneously and closed using a suture device, while the other access sites were managed surgically. Two commercially available systems were used: a self-expandable prosthesis, namely the Medtronic CoreValve Revalving System (Medtronic, Minneapolis, Minnesota, USA); a balloon-expandable prosthesis, the Edwards SAPIEN valve (Edwards Lifesciences, Irvine, California, USA). All patients provided written informed consent before the TAVI procedure.
5
Hybrid Operating Room Optimized TAVR
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All TAVRs were performed in a dedicated hybrid operating room offering full functionality for cardiac catheterization, anesthesiology, and cardiac operations, and a cardiopulmonary bypass circuit and clinical perfusion team were kept on standby. Competences of the interdisciplinary heart team, consisting of cardiac surgeons, cardiologists, anesthesiologists, and perfusionists, complemented in optimal support during the TAVR procedure. TAVR was performed with different currently commercially available transcatheter heart valves: SAPIEN and SAPIEN XT (Edwards Lifesciences, Irvine, CA), the CoreValve ReValving System (Medtronic Inc, Minneapolis, MN), and the ACURATE-TA (Symetis S.A., Ecublens, Switzerland). TAVR was performed by transapical, transaortic, or transfemoral access. Technical aspects of the different TAVR procedures and access sites have been described previously by our group [8] [9] [10] .
6
Transfemoral Transcatheter Aortic Valve Implantation
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The third-generation Medtronic CoreValve ReValving System (Medtronic, Minneapolis, Minnesota, United States) was implanted by the same operator in all patients by transfemoral approach with double Pro-Glide (Abbott Vascular, Redwood City, California, United States) preclosing, as previously published.
10 (link)
Procedures were performed under anticoagulation by a bolus of unfractionated heparin at weight-adjusted dose.
The clinical endpoints after TAVI were described following Valve Academic Research Consortium-2 definitions.
11 (link)
In-hospital clinical, biological, and transthoracic echocardiography (TTE) follow-up was performed before discharge. Active 30-day follow-up was obtained in all survivors by outpatient visit or direct contact with their cardiologist. All events and values were prospectively site recorded.
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The third-generation Medtronic CoreValve ReValving System (Medtronic, Minneapolis, Minnesota, United States) was implanted by the same operator in all patients by transfemoral approach with double Pro-Glide (Abbott Vascular, Redwood City, California, United States) preclosing, as previously published.
10 (link)
Procedures were performed under anticoagulation by a bolus of unfractionated heparin at weight-adjusted dose.
The clinical endpoints after TAVI were described following Valve Academic Research Consortium-2 definitions.
11 (link)
In-hospital clinical, biological, and transthoracic echocardiography (TTE) follow-up was performed before discharge. Active 30-day follow-up was obtained in all survivors by outpatient visit or direct contact with their cardiologist. All events and values were prospectively site recorded.
7
Transfemoral Transcatheter Aortic Valve Implantation
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A temporary pacing wire was advanced into the right ventricle via a 7-F sheath in the femoral vein. A 7-F arterial sheath was inserted for angiography and for the coronary measurements with a guiding catheter. An 8-F sheath was inserted in the other femoral artery for balloon valvuloplasty and valve implantation. Nine patients were treated with the CoreValve Revalving System (Medtronic, Minneapolis, MN) and 6 patients with the Edwards SAPIEN/SAPIENXT bioprosthesis (Edwards Lifesciences, Irvine, CA) at the discretion of the operator. The procedure was performed under general anesthesia (n=4) or with local anesthesia in combination with a mild systemic sedative (n=11). Transthoracic echocardiography was performed preprocedurally and 2 to 5 days after TAVI.
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